MAUDE Adverse Event Report: THE HONEY POT COMPANY LLC 100% ORGANIC COTTON COVER EVERYDAY LINERS: HERBAL-INFUSED LINERS; PADS, MENSTRUAL, SCENTED-DEODORIZED

Lot Number	220531-8735
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I used a sanitary liner for feminine hygiene at target on the evening of (b)(6) 2023 at approximately 8pm.The brand is called the honeypot company.Within 10-20 seconds of having the liner on, i experienced intense burning.I jumped in the shower within 3-4 minutes to attempt to wash off whatever substance was causing the burning.I experienced relief immediately after washing.However, approximately 7 hours later i began experiencing soreness in the same area where the liner had touched.And then i did get a milder burning sensation as well shortly after the pain.Within 24 hours pain has increased slightly and the irritation seems to have increased slightly.I have not been to a doctor.This is a feminine hygiene product yet it has mint, lavender, aloe and menthol in it.I did not look closely at the packaging when purchasing but it states "herbal infused liners".It has a very strong herbal smell almost as if it had been soaked in these things.I searched the internet after my experience and found numerous complaints about this product burning people and in some cases severe irritation lasting days and in one case, a diagnosed infection.

• Brand Name: 100% ORGANIC COTTON COVER EVERYDAY LINERS: HERBAL-INFUSED LINERS
• Common Device Name: PADS, MENSTRUAL, SCENTED-DEODORIZED
• Manufacturer (Section D): THE HONEY POT COMPANY LLC; 1115 howell mill rd nw; ste 750; atlanta GA 30318
• MDR Report Key: 17643091
• Report Number: MW5145032
• Device Sequence Number: 7331522
• Product Code: NRC
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 220531-8735
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White